ObjectivesA regulatory T cell (Treg) insufficiency due to shortage of interleukin-2 (IL-2) is central to the pathophysiology of systemic lupus erythematosus (SLE). We performed a multicentre, double-blinded, randomised, placebo-controlled phase II proof-of-concept trial to evaluate the efficacy of low-dose IL-2 therapy in patients with SLE having moderate-to-severe disease activity while receiving standard treatment.MethodsWe randomly assigned 100 patients in a 1:1 ratio to receive either 1.5 million IU/day of subcutaneous IL-2 (ILT-101) or placebo for 5 days followed by weekly injections for 12 weeks. Clinical efficacy was assessed at week 12 in a predefined hierarchical analysis of (1) the SLE responder index-4 (SRI-4) response as a primary end point, and of (2) relative and (3) absolute changes in the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index scores as key secondary end points.ResultsThe primary end point was not met in the intention-to-treat population (ILT-101: 68%, placebo: 58%; p=0.3439), due to a 100% SRI-4 response rate in the placebo group from the two sites from Bulgaria. A post hoc per-protocol analysis on a prespecified population that excluded patients from these two sites (n=53) showed a statistically significant difference for the SRI-4 response rate (ILT-101: 83.3%; placebo: 51.7%; p=0.0168), and for the two key secondary end points, accompanied by differences in several secondary exploratory end points. ILT-101 was well tolerated and there was no generation of antidrug antibodies.ConclusionsThe post hoc hierarchical analysis of the primary and key secondary end points in a per-protocol population, complemented by the exploratory analyses of multiple other secondary end points, support that low-dose IL-2 is beneficial in active SLE.Trial registration numberNCT02955615.
Food security has become a prominent issue in northern Canada. Many constraints, including environmental, cultural and economic barriers to cause food insecurity in northern Canada where local food production is one proposed solution to the northern food crisis. Initiated at McGill University by the Biomass Production Laboratory, the Canadian Integrative Northern Greenhouse (CING) unit provides a completely integrative design solution that could allow northern Canadian communities to grow their own fresh and nutritious food year-round. The CING unit is a hybrid between a northern greenhouse and a growth chamber housed in a shipping container, designed to be adaptive by functioning as a typical solar greenhouse when solar light provides considerable heat and light, and as a closed growth chamber during the night and when colder, darker winter conditions prevail. The CING was designed and prototyped by McGill students since 2013. Lettuce was grown during the four-season test of the CING, the greatest yield obtained was in March 2019, where the plants grown achieved 72% of the dry mass of the plants grown in the research greenhouse. The CING relied on supplemental heating to successfully grow plants but demonstrated the potential for northern and remote applications.
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